Clinical and vaginal microbiota effects of oral Lactobacillus crispatus M247 combined with vaginal laser therapy in menopausal women with atrophic vulvovaginitis: a prospective, randomized and controlled study

Vaginal atrophy is a common condition in postmenopausal women, frequently associated with vaginal symptoms and alterations of the vaginal microbiota. This randomized study evaluated the clinical and microbiological effects of vaginal CO₂ laser therapy administered alone or in combination with an oral probiotic containing L. crispatus M247 in postmenopausal women with vulvovaginal atrophy. Women were randomized (2:1) to receive vaginal laser therapy alone (laser-only group) or laser therapy plus oral probiotic for 90 days (probiotic plus laser group). Clinical efficacy was assessed through a prespecified panel of outcomes, including vaginal pH and symptom severity assessed by Visual Analogue Scale (VAS), at baseline and during follow-up up to 90 days, with Day 90 representing the main efficacy timepoint. Vaginal microbiota composition was analyzed in a subset of participants. Both groups showed improvement over time in vaginal pH and VAS scores for vaginal dryness, dyspareunia, burning, itching, and introital pain. Compared with laser alone, the probiotic plus laser group showed lower symptom scores at Day 90 in selected clinical domains, with effect estimates generally favoring the probiotic plus laser group, although confidence intervals were relatively wide for some endpoints. P-values for individual outcomes should be interpreted as nominal in the absence of prespecified multiplicity adjustment across clinical domains. For vaginal pH, both groups showed a decrease over time, but the group × time interaction was not statistically significant, indicating no clear differential temporal response. Microbiota analysis showed an increase in the relative abundance of L. crispatus and a concomitant decrease in L. iners only in the probiotic plus laser group, suggesting a shift toward a more favorable vaginal microbial profile. Overall, vaginal CO₂ laser therapy was associated with clinical improvement, and adjunctive treatment with L. crispatus M247 was associated with additional benefits across selected clinical and microbiological outcomes; however, confidence intervals for several clinical estimates were relatively wide, supporting cautious interpretation and confirmation in larger blinded studies.